Two prominent anti-smoking researchers – Dr. Michael Siegel of the Boston University School of Public Health and Dr. Alan Blum of the University of Alabama – are today calling for the resignation of Dr. Jonathan Samet, the chair of the newly appointed FDA Tobacco Products Scientific Advisory Committee, which is in the second day of its inaugural meeting today.

Dr. Samet received tobacco industry funding to help craft the scientific agenda for the now-defunct industry front group: the Center for Indoor Air Research. To the best of our knowledge, he has never publicly acknowledged and apologized for having played this role for the industry and he failed to even mention his history of tobacco funding when he published an article which scolded other scientists for accepting tobacco money to help the industry disseminate “junk science” to foster its opposition to smoke-free policies.Dr. Samet refused to answer our questions about his past involvement with the tobacco industry, instead referring our questions to the FDA.

The chairman of the newly created FDA scientific advisory panel on tobacco products, which holds its first meeting on March 30, helped the tobacco industry set a research agenda aimed at casting doubt on the harm caused by secondhand cigarette smoke. Dr. Jonathan Samet, a professor of preventive medicine at the University of Southern California, was one of six scientists enlisted in 1989 by the Center for Indoor Air Research (CIAR), a tobacco industry front group.

In the 1980s mounting scientific evidence of the harmfulness of secondhand smoke led to the passage of numerous state and local smoking bans in public places, culminating in the 1988 ban by Congress on smoking on all domestic airlines. Moreover, the Environmental Protection Agency (EPA) was about to consider whether to name secondhand smoke as a cause of cancer.

In response, America's three leading cigarette companies, Philip Morris USA (maker of the top-selling US brand, Marlboro), RJ Reynolds Tobacco Company (Winston, Camel), and Lorillard Inc (Newport) teamed up to establish CIAR. Tobacco company lawyers were present at all meetings of CIAR's Board of Directors and were involved in all of its decisions. In her scathing, 2000-page opinion in the Department of Justice lawsuit against the tobacco industry for racketeering, Judge Gladys Kessler exposed the fraudulent nature of CIAR: "During the entire existence of CIAR (1988-1999) only cigarette company executives/scientists sat on the Board of Directors...Despite the establishment of a functioning Scientific Advisory Board (SAB), only the CIAR Board of Directors had authority to approve the funding of any CIAR project." Judge Kessler also noted that in none of the 19 issues of CIAR's quarterly newsletter was it disclosed that the Center was funded and controlled by the tobacco industry.

Dr. Samet's relationship with the industry surfaced in 1990, when the Associated Press reported that he and five other members of a 16-person EPA scientific advisory panel charged with evaluating studies on the health effects of secondhand smoke were identified as having ties to CIAR. In its 1989-1990 Request for Applications (RFA) from researchers, CIAR acknowledged Samet and others "for their assistance in the development of the Center's first research agenda by making presentations at the Scientific Advisory Board Workshop." CIAR's 1991 RFA thanks Samet and others "for their intense efforts and active participation." Samet accepted payment from the tobacco industry for his participation in the workshop, including travel expenses and an honorarium paid to his academic institution, the University of New Mexico, where he served as a professor in the Department of Family, Community, and Emergency Medicine.

Samet has previously acknowledged: "With regard to the Center for Indoor Air Research, I participated for one day in a workshop at which I gave my opinions concerning research needs on indoor air pollution. On one occasion I have served as an external peer reviewer of grants by mail. For these activities I received reimbursement for expenses. I did not accept honoraria, but submitted them to my institution." Yet the fact remains that the newly appointed chair of the first scientific panel appointed to advise the FDA on the regulation of tobacco products accepted tobacco money to help craft the research agenda for an organization that proved to be a fraudulent scientific enterprise.

Ironically, in 2001 Samet published a paper in the American Journal of Public Health in which he criticized the tobacco industry's use of "junk science" to undermine the scientific evidence linking secondhand smoke and adverse health effects. Samet wrote: "The lesson? The stakes are high in the public policy arena. Public health scientists will continue to be called on to research society's most vexing issues, and to inform and shape the public policy response. We need to be aware of the competing interests and to work for greater transparency to assure ourselves that we understand the purposes and funding sources of potentially invidious meetings and other activities." The junk science and corruption he was condemning was precisely the enterprise in which he had participated at a time when the tobacco industry was redoubling its efforts to cast doubt on the impact of secondhand smoke.

Yet nowhere in Samet's paper does he acknowledge having played a role, even inadvertently, in this scheme. Nor did this inhibit Samet from calling for greater awareness of competing interests and transparency, scolding other scientists, and according to a published article by Dr. Carl Phillips (in the journal Epidemiologic Perspectives and Innovations), even urging attendees at a conference to boycott a session of a scientific meeting at which a tobacco industry-funded scientist was to present a paper on the effects of secondhand tobacco smoke.

In light of these revelations about Dr. Samet, he should end his participation in the FDA Tobacco Products Scientific Advisory Committee.

Numerous scientists have worked for decades to address tobacco problems without the need to accept funding from cigarette manufacturers or to associate themselves with the tobacco industry's obfuscatory research agenda. Surely, in its first try at ending the smoking pandemic, the FDA should be able to identify a scientist free of the taint of Big Tobacco to serve as chair of its scientific advisory committee.

Michael Siegel, MD, MPH - Professor, Boston University School of Public Health

Alan Blum, MD - Professor and Endowed Chair in Family Medicine and Director of the University of Alabama Center for the Study of Tobacco and Society

Dr. Michael Siegel is a long-time tobacco control researcher and advocate for tobacco control policies, fairly well known in the tobacco control area. He is a physician who specializes in preventive medicine and public health. He is now a professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 23 years of experience in tobacco control, primarily as a researcher. He has over 60 published, peer-reviewed articles on tobacco control policy in such journals as the New England Journal of Medicine, JAMA, American Journal of Public Health, Tobacco Control, Journal of Marketing, and the American Journal of Epidemiology. He is author of three previous op-eds on tobacco policy published in the Washington Post, New York Times, and USA Today. His work on the health effects of secondhand smoke on bar and restaurant workers is widely cited in public policy debates over smoke-free bar and restaurant policies. He has been a long-term advocate for smoke-free bar and restaurant policies, and have testified on behalf of such laws in more than 50 cities throughout the country. His areas of research interest include the health effects of secondhand smoke, policy aspects of regulating smoking in public places, effects of cigarette marketing on youth smoking behavior, and the evaluation of tobacco control program and policy interventions.

Dr. Alan Blum is a family medicine physician and a long-time veteran of the anti-tobacco movement. He is now Professor and Director of the Center for the Study of Tobacco and Society at the University of Alabama. Dr. Blum formerly served as Editor of the New York State Journal of Medicine, where he published the first journal issue dedicated to tobacco articles. Dr. Blum has published extensively on tobacco policy, with a specialty in tobacco marketing and advertising. He is the founder of Doctors Ought to Care, a national organization which has involved physicians in tobacco control advocacy, an effort for which he received the first National Public Health Award from the American Academy of Family Physicians.

Tuesday, March 30, 2010

St. Luke's Hospital and Health Network announced Monday that it will no longer consider job applications from smokers, or from anyone who uses nicotine. Prospective employees will be screened for nicotine and if they test positive, their applications will be thrown in the garbage, according to the new policy which goes into effect on May 1. Existing employees will not be affected.

A local anti-smoking group expressed approval of the new policy: "Alice Dalla Palu, executive director of the Coalition for a Smoke-Free Valley, said policies against hiring smokers may be something employers should look at, especially as a way to save on health-care costs. ''It's something to consider,'' she said."

The Rest of the Story

St. Luke's is essentially making the statement that smokers should not be working in the health care field. I wonder how St. Luke's feels about overweight people working in the health care field. Is that acceptable? After all, people who are obese run up much higher medical bills than people who are of normal weight. Is St. Luke's also going to weigh potential employees and throw out the applications of anyone whose body mass index is at an unhealthy level?

If it's appropriate to refuse to hire smokers in order to reduce health care costs, then it is also appropriate to refuse to hire overweight people to reduce health care costs.

But how would most people view a hospital system that put prospective employees on a scale prior to hiring them? I think most of us would view such an employer with great scorn. We would criticize the employer for discriminating against overweight individuals. We would be concerned about what would happen if all employers acted in a similar manner. Overweight people would have a hard time finding jobs. It seems quite unfair to discriminate against people because of lifestyle choices they have made which have no direct bearing on their job qualifications.

The same is true of employment discrimination against smokers. It is unfair and inappropriate. Instead of applauding such actions, anti-smoking groups should speak out against this form of employment discrimination.

The appropriate way to reduce health care costs related to smoking is to offer workplace wellness programs, including smoking cessation programs and benefits. Such programs have been shown to be cost-effective. Refusing to hire people with unhealthy behaviors is not an appropriate public health approach to the problem.

Monday, March 29, 2010

On his new blog over at BMJ Group Blogs, Patrick Basham criticizes the UK Department of Health's new tobacco control strategy for lack of an evidence base in its smoking cessation recommendations.

Basham writes: "The strategy document says, “Those who are most successful in quitting use a combination of behavioural and medicinal support.” (p. 11) The only support for this rather extraordinary assertion is an unpublished report by West entitled, “The smoking pipe: a model of inflow and outflow of smokers in England.” But this source, which is a single page spreadsheet, provides little support for the claim about cessation. More troubling is that the DoH’s claim about the best way to quit smoking fails the most basic test of evidence-based medicine: it is contradicted by much of the published literature."

Basham then goes on to cite numerous published papers documenting that unassisted smoking cessation is more effective than quit attempts aided by pharmaceuticals and that unplanned quit attempts (i.e., cold turkey) is far more effective than planned quit attempts that typically rely upon pharmaceutical aids. Basham also cites evidence that on a population level, the majority of successful quit attempts do not involve pharmaceutical therapy, including the American Cancer Society's estimate that 90% of people who have quit smoking have done so without medicinal aids.

Basham concludes: "Despite the DoH and the pharmaceutical industry’s promotion of pharmaceutically-aided cessation, the evidence suggests that unassisted cessation, not behavioural and medicinal support, is the method used most often by those who quit smoking successfully. Perhaps, the only people who find this surprising or dismaying are those in the pharma-nicotine industry. Both physicians and their patients have an unqualified right to expect that the DoH provide scientifically accurate and objective information about smoking and tobacco control policy. The DoH has failed both the profession and the public in its claims about smoking cessation."

The Rest of the Story

I welcome Patrick Basham's blog, which promises to be a very important addition to the tobacco blogosphere. This inaugural column provides a concise, compelling, and poignant argument that the UK Department of Health's national tobacco control strategy fails the public in its recommendations concerning smoking cessation because it ignores the scientific evidence base and makes suggestions that are inconsistent with that evidence.

For example, the document asserts: "It is important to recognise that millions of smokers who want to quit – despite efforts to persuade them to seek support – will choose to go ‘cold turkey’, the least successful approach to quitting." This statement is inconsistent with the published literature, which demonstrates the exact opposite. The danger of relying upon such a claim is that it would lead to a dramatic reduction in smoking cessation if we discouraged cold turkey quit attempts and instead, tried to ensure that every smoker trying to quit goes through the government's pharmaceutical-based smoking cessation program.

The strategy document makes the unsupported claim that "Smokers who stop smoking with NHS support are up to four times more likely to stop successfully compared with smokers who stop without any form of support." No support is provided for this claim and I have been unable, on repeated attempts, to find any support for such a statement. As Basham concisely summarizes, the scientific literature demonstrates that the exact opposite is true: unaided cessation has been shown to be far more effective than drug-based cessation efforts.

How does the UK Department of Health support its statement that smokers using the NHS support were four times more likely to quit smoking? It cites a 2005 paper in Addiction which examines the 52-week prolonged abstinence rate for a cohort of subjects who utilized NHS support in a particular location (reference 48 in the report). That paper reports a 14.6% one-year prolonged abstinence rate among this cohort.

The problem? The study was not designed to compare the quitting rates for those who did and did not use the NHS support system. In fact, the study did not even measure the cessation rate for those who did not use NHS support. It was not a controlled study. There was simply an intervention group, but no comparison group. So how can the study possibly conclude that those who used the NHS support system were four times more likely to quit smoking?

Well, it doesn't. Nowhere in the paper is the assertion made that the NHS support yields smoking cessation rates that are four-times higher than cold turkey quitting. It seems that the Department of Health is citing a paper as supporting its conclusion when that paper does nothing of the sort. Perhaps they thought that nobody would actually take the time to read reference 48, but they were wrong. I guess they did not know about The Rest of the Story.

The rest of the story is that you can't simply compare the rates of quitting found in that study with published rates of overall quitting success because you're dealing with very different populations in terms of motivation to quit smoking. The only valid way to compare these rates would be to ensure that the two groups are equivalent in terms of motivation to quit smoking. Those who opt to use NHS support services are probably a more highly motivated group than the set of all smokers who make a quit attempt. To make the comparison that the Department of Health makes, one would have to do a study where you randomized subjects to either receive or not receive NHS support services. I'm aware of no such study.

We do, however, have an abundance of scientific evidence that refutes the claims made in this report.

When it comes down to it, I believe that cold turkey smoking cessation is the most effective way to quit and that is precisely what we should be aiming for. Smokers need to be highly motivated to quit and that level of motivation has to be high enough that the smoker just decides to go cold turkey and forgo a reliance on nicotine therapy or other drugs.

Others can certainly disagree with my conclusion, but to make unsupported claims that are not backed by the evidence base is, as Basham argues, a disservice to the public.

Friday, March 26, 2010

A new report by the Royal College of Physicians (RCP) calls for policies to protect children from ever having to see smokers.

The report "identifies ways in which smoke-free legislation could be improved to afford greater protection to children. Most importantly, it calls for a radical rethink of the acceptability of smoking anywhere in the presence of children. One of the biggest impacts of smoking around children is that adult smokers can be seen as role models, increasing the likelihood that the child will, in due course, also become a regular smoker."

The report calls for smoking bans in "outdoor places frequented by children."

According to the report: "One of the biggest impacts of smoking around children is that adult smokers can be seen as role models, increasing the likelihood that the child will, in due course, also become a regular smoker. ... The existing smoke-free legislation protects children in enclosed public places but does not prevent exposure to smoke, or to smoking behavioural models, in the home, in vehicles, in unenclosed public places, and the many other places where children spend time. ... All of the harms caused by passive smoking, including the direct health effects and effects on smoking uptake summarised above, are preventable by protecting children from exposure not just to cigarette smoke, but from exposure to smokers."

The report concludes: "Children are potentially exposed to passive smoking wherever people smoke, and to the smoking behavioural model wherever they see people smoking. The extension of smoke-free regulations to include areas frequented by children, as outlined in section 11.1 above, would prevent both of these exposures. ... Smoke-free legislation should therefore include all public places frequented by children, whether or not enclosed as currently defined in law, andshould include private vehicles."

The Rest of the Story

It is now official. The tobacco control movement is now using the protection of children from having to see smokers as a justification for promoting bans on smoking in outdoors locations. The Royal College of Physicians readily admits that it is not about the smoke, it is about the smoker. The goal now is to protect children not merely from exposure to tobacco smoke, but from even having to see a smoker in public.

Since children frequent virtually all outdoor places, if one follows the Royal College of Physicians' recommendation, one would have to ban smoking everywhere outdoors. Essentially, then, the RCP is calling for a ban on smoking everywhere outdoors.

The same justification being used to support banning smoking in cars could be used to support banning smoking in the home. If the government is justified in telling parents that they cannot expose children to tobacco smoke in cars, then why is the government not justified in telling parents they cannot expose children to tobacco smoke in homes?

By the RCP's reasoning, smoking should literally be banned everywhere except inside homes in which no child lives.

The problem with the RCP report is that it undermines the justification for smoking bans where they are really needed (i.e., in the workplace) by obfuscating the actual reason to promote such bans (i.e., to protect nonsmokers from high levels of exposure to tobacco smoke that they cannot easily avoid).

Curiously, the RCP is not also calling on prohibiting people from eating junk food in places where they can be seen by children. But the same reasoning that would justify banning smoking outdoors (to prevent children from having to see smokers) would also justify banning the consumption of junk food in public (to prevent children from having to see the consumption of junk food).

The rest of the story is that the Royal College of Physicians has gone off the deep end and lost sight of the real art of public health: balancing the protection of health with individual freedom and autonomy. With that, they are going to undermine important efforts to protect nonsmokers from secondhand smoke because they are obscuring and undermining the justified elimination of secondhand smoke from places where nonsmokers are heavily and chronically exposed and cannot easily avoid the exposure. They are also undermining the field of public health itself by completely losing sight of the need to balance health protection with individual freedom and autonomy.

Thursday, March 25, 2010

An article by Dr. Michael Marlow, a Professor at California Polytechnic State University in San Luis Obispo, questions the conclusions of many anti-smoking groups and researchers, including the Institute of Medicine (IOM) committee which examined the issue, that smoking bans lead to dramatic, immediate reductions in heart attacks. An IOM committee concluded that the scientific evidence is sufficient to conclude that smoking bans significantly reduce heart attacks, although the committee was unwilling to estimate the magnitude of the effect. The article appears in the spring issue of the Journal of American Physicians and Surgeons.

Dr. Marlow points out a number of severe weaknesses in the existing studies which were purported to show that smoking bans caused reductions in heart attacks. First, the sample sizes are quite small and only select communities are studied. In contrast, a systematic study of all communities in the U.S. found no effect of smoking bans on heart attack mortality rates. The reason for the positive findings of these small sample studies may be publication bias. Researchers may not pursue the publication of negative findings or such studies may have a more difficult time finding acceptance in journals.

Second, very few of the studies examined smokers and nonsmokers separately. Thus, they cannot possibly conclude that any observed reduction in heart attacks is attributable to decreased secondhand smoke exposure, rather than lower rates of smoking. Nevertheless, this methodologic flaw does not stop most of the researchers from drawing such a conclusion.

Third, none of the studies account for other secular changes that could explain an observed reduction in heart attacks. The most important of these variables is improved treatment of cardiovascular disease.

Fourth, the kinds of dramatic changes in heart attacks that are being attributed to smoking bans in some studies are simply implausible. Even if all secondhand smoke were to be instantly eliminated, epidemiologic calculations would not predict anything as high as a 47% reduction in heart attacks.

Dr. Marlow concludes: "Publicly led research on public health effects of smoking bans has overstated benefits by overreaching on conclusions, excluding studies that contradict predetermined conclusions, and relying on studies subject to biases outlined above. This pattern is lamentable for a number of reasons. One is that efforts claiming to improve public health appear to be driven more by social agendas than by science. The IOM released, and various media outlets promulgated overstated claims on the public benefits of smoking bans, apparently without even considering whether they met the simplest tests of believability."

The Rest of the Story

I agree that the overreaching on conclusions and cherry-picking of studies by anti-smoking groups and researchers is lamentable. Perhaps the most troubling example is the IOM committee itself, which failed to consider the considerable data which failed to show any effect of smoking bans on heart attacks.

I also agree that over-reaching on conclusions has unfortunate deleterious effects. Perhaps the greatest one is the potential for undermining the public's trust in public health. If health groups exaggerate scientific information to the public, then the public may discount very important, valid messages that these same groups offer in the future. An excellent example of this is the very low rates of immunization for H1N1 influenza, which I think is largely attributable to over-exaggeration of the risks of a worldwide pandemic. When the public saw that the dire warnings never materialized, they lost confidence in anything public health groups had to say about the H1N1 flu. This is unfortunate, because it still is a very serious epidemic and resulted in more than 10,000 deaths.

The most prized possession of public health is its credibility. Lose that, and we lose our ability to communicate vital messages to the public and have them taken seriously. Anti-smoking groups are not doing themselves any favors in the long run by risking their credibility and throwing their scientific integrity to the wind.

Wednesday, March 24, 2010

An anti-smoking researcher has warned the public not to be around cigarette smokers, according to a press release issued by the University of Cincinnati.

The press release is related to a new research study which reports that a particular genetic trait may predispose certain individuals to higher risks of lung cancer, even if they are exposed to lower doses of tobacco smoke than are typically associated with high risk for lung cancer.

According to the press release: "For family members without this genetic lung cancer risk, the risk of developing the disease tracked closely with the level of smoking—in other words, heavy smokers had a significantly greater risk of developing lung cancer than moderate smokers, who had a significantly greater risk than light smokers. But in family members with the genetic risk haplotype, even light smoking resulted in a greatly increased risk for developing lung cancer. From there, increasing smoking behaviors in this group of family members carried only weakly increasing risk for developing lung cancer. "If you carried the inherited risk and then you smoked, it didn’t matter if you were a light smoker or a heavy smoker—you were significantly more likely to develop lung cancer,” Pinney says. Adds Anderson: "If you have a family history of lung cancer, you probably should not even be around cigarette smokers.”

"Marshall Anderson, PhD, a professor in UC’s cancer and cell biology department, is principal investigator of the GELCC [Genetic Epidemiology of Lung Cancer Consortium], whose UC portion is known as the Family Lung Cancer Study. Susan Pinney, PhD, an associate professor in the department of environmental health, is a co-investigator."

The Rest of the Story

The interesting aspect of this story is that the researcher did not warn the public to avoid being around cigarette smoke, or to avoid being around cigarette smokers when they are smoking. Instead, the advice was simply to avoid being around smokers, period.

Now one might argue that this was simply a word slip and that the researcher's intended statement was to avoid exposure to smoke. However, the fact that she had plenty of time to review her statement in this press release suggests that at least some thought went into the language she used. If not intentional, it was at least a Freudian slip that her advice was to stay away from smokers.

This might be a matter of semantics, except for the fact that it seems symbolic of a growing trend in the tobacco control movement, whereby the distinction between a battle against cigarette smoke and one against cigarette smokers is becoming increasingly blurred. Anti-smoking groups, for example, are now supporting not only smoke-free workplaces, but also smoker-free workplaces. Such policies are obviously not designed to protect nonsmokers from cigarette smoke, but from cigarette smokers. The same is true of policies banning smoking completely on college campuses and in remote outdoor locations.

Do we really want to turn smokers into social outcasts? Do we really want to advise people not to associate at all with anyone who smokes (even when they are not smoking)?

In previous times, I would have said: "Absolutely not. Our goal is simply to protect nonsmokers from secondhand smoke." Today, I'm not so sure. In fact, that's not true. I am sure. I am sure that many in the anti-smoking community have exactly that as a goal: the punishment, social isolation, and ostracization of smokers.

Sunday, March 21, 2010

Would Also Criminalize Individuals Who Give Electronic Cigarettes to Friends or Relatives to Help Them Quit Smoking

Bill Acknowledges that Deadly Analog Cigarettes are Approved by the FDA, and that State Lawmakers Would Rather People Smoke the Deadly Ones than the Much Safer Electronic Ones

The Maryland legislature is considering a bill which would ban the sale and distribution of electronic cigarettes. House Bill 720 makes it a crime (a misdemeanor) to sell someone or give someone an electronic cigarette.

The bill is intended to protect children from taking up vaping.

Specifically, the bill bans any nicotine-delivering product which is not approved by the FDA.The Rest of the Story

Electronic cigarettes have been extensively studied in the laboratory and we have a pretty good idea of what is in them. While we don't know if they are absolutely safe, we do know that they are likely much safer than regular cigarettes.

Laboratory testing has revealed that electronic cigarettes contain mainly propylene glycol, glycerin, and nicotine. There are traces of other chemicals, none of which has been implicated as a health hazard at the concentrations present in the electronic cigarette (with the one exception of diethylene glycol, but that was only found in one e-cigarette brand and many other brands tested have been shown to be free of diethylene glycol).

We do know that electronic cigarettes contain only traces of carcinogens. In fact, the level of carcinogens in these products are comparable to levels present in nicotine replacement products like nicotine gum and the nicotine patch. Importantly, the concentration of carcinogens in electronic cigarettes is orders of magnitude lower than in regular cigarettes.

We also know that many smokers have found electronic cigarettes to be highly effective in helping them to quit smoking and to stay off cigarettes. There are literally thousands of people who would almost certainly return to regular cigarette smoking if electronic cigarettes were taken off the market.

The rest of the story, then, is that House Bill 720, if enacted, would be devastating to the health of the people of Maryland. It would force many ex-smokers in the state to return to cigarette smoking. Thus, it would cause substantial public health harm.

Electronic cigarettes appear to be a much more effective tool for quitting smoking than traditional nicotine replacement therapy. And they certainly appear to be a much safer alternative to cigarettes for smokers who are unable to stop using nicotine products completely.

To take electronic cigarettes off the market is to deny smokers a much safer alternative that is likely saving lives and improving the public health. That such a bill is being considered as a public health measure suggests that the Maryland legislature simply has not taken the time to properly study the issue of electronic cigarettes.

With all of the facts in hand, I don't see how any legislator who is truly interested in protecting the public's health and saving lives could possibly support legislation to take e-cigs off the market, forcing ex-smokers to return to the much more toxic analog cigarettes. Let's hope that the Maryland legislators take the time to research and inform themselves about this issue before they vote on this bill.

There are two other interesting aspects of this story that deserve note.

First, the legislation makes it clear that in the eyes of the Maryland legislature, the FDA has approved real cigarettes for sale and marketing in the United States. After all, we can assume that House Bill 720 is not intended to ban the sale of cigarettes. However, the bill bans the sale of all nicotine-delivering products that are not FDA-approved. Since cigarettes are a nicotine-delivering product, they would be banned by this bill if not FDA approved.

Unfortunately, the sad but true fact is that thanks to our friends at the Campaign for Tobacco-Free Kids and other national anti-smoking groups, analog cigarettes are indeed FDA-approved.

The irony of this whole situation is that the Maryland legislature wants people to smoke the real, FDA-approved cigarettes in lieu of the much safer electronic ones, which have been shown to deliver up to 1400 times less carcinogens.

Why would a public policy maker in Maryland prefer that smokers die than that they quit smoking by using a device which is orders of magnitude safer than the FDA-approved cigarettes?

There are only 3 reasons I can think of:

1. They want to protect the sale of cigarettes, and the profits of the tobacco companies, in Maryland.

2. They want to protect the profits of the pharmaceutical companies which manufacture nicotine replacement products which help only a very small percentage of smokers quit smoking.

3. They are uninformed about the health issues regarding analog cigarettes compared to electronic cigarettes and therefore have no real idea what they are doing, but are blindly following the misguided advice of the anti-smoking groups.

A second additional aspect of this story that deserves attention is that if House Bill 720 is enacted, it will be a crime for an individual to give a friend or relative an electronic cigarette to help them quit smoking.

Frankly, giving the gift of an electronic cigarette to a friend or relative who is a smoker who has had trouble quitting via other means is one of the most compassionate things a person can do. To make that person a criminal makes no sense at all.

Supporters of the legislation say it is needed to protect kids from taking up vaping. But the bill goes far beyond such a purpose. If that were the true purpose, then the bill should simply ban the sale or distribution of electronic cigarettes to persons under the age of 18. That would be a very reasonable measure to help ensure that young people do not get their hands on these products. However, the bill goes far beyond this by banning electronic cigarettes entirely in Maryland.

Despite the fact that there is absolutely no evidence that electronic cigarettes are popular among youths or that youths will be willing to spend the $60 to $120 necessary to obtain a starter kit, it is still reasonable to ensure that the products cannot be sold or distributed to minors. But it is not necessary to ban the sale of electronic cigarettes outright to achieve this purpose.

If legislators in Maryland are truly interested in protecting the public's health, they will take action to ensure that the ex-smokers who quit smoking via use of electronic cigarettes will continue to have access to these products and will not have to return to the highly toxic real ones.

Thursday, March 18, 2010

Negative Finding Doesn't Stop Researchers from Telling the Media that They Found an Effect

Another published study - this one in the Australian and New Zealand Journal of Public Health - fails to provide evidence that smoking bans result in dramatic, immediate reductions in heart attacks, as claimed by many anti-smoking researchers and groups and as claimed by an Institute of Medicine committee that reviewed the scientific evidence (see: Barnett R, Pearce J, Moon G, Elliott J, Barnett P. Assessing the effects of the introduction of the New Zealand Smokefree Environment Act 2003 on acute myocardial infarction hospital admissions in Christchurch, New Zealand. Australian and New Zealand Journal of Public Health 2009; 33:515-520).

The study examined the effects of New Zealand's smoking ban, implemented in December 2004, on first-time acute myocardial infarction (i.e., heart attack) admissions to Christchurch Hospital during the two years before and after the smoking ban. Thus, the baseline period was January 2003 through December 2004 and the intervention period was January 2005 through December 2006.

The researchers found that the overall rate of heart attack admissions declined by 5.1% from 2003/2004 to 2005/2006. They did not include any comparison group nor go further back in time to assess whether this level of decline was similar to pre-existing secular trends or to trends in other countries.

When examining the raw data (see Figure 1 in the paper), it is quite clear that there is no significant effect of the smoking ban on heart attack admissions. In fact, the number of heart attacks during the winter of 2006 was higher than during any other winter during the study period.

The graph also suggests that there has been a slight increase in heart attacks during 2006. The number of heart attacks was higher in 2006 than in 2005 during the last eight months of that year.

The paper accurately concludes that the evidence provided does not allow one to conclude that the smoking ban resulted in a significant decline in heart attacks. As noted in the paper: "it is possible that the observed decline in AMI admissions is a manifestation of long-term secular trends, for example in statin prescription, reduced excess winter mortality or dietary change, that have operated synergistically alongside the national smokefree policy introduced in 2004."

In other words, in the absence of any control group or any comparison to existing secular trends, it is not possible to attribute the small observed decline in heart attacks to the smoking ban. The paper's authors acknowledge this in the manuscript and because of this weakness, conclude that the present evidence does not support a conclusion that the smoking ban led to a significant reduction in heart attacks.

Nevertheless, one of the study authors apparently told the media: "This short-term research indicates a link between a smoking ban in bars and restaurants and a reduction in severe heart attacks." The media certainly got the impression that the researchers were concluding that the smoking ban led to a decline in heart attacks.

Finally, despite their conclusion within the paper that the evidence is not sufficient to conclude that the smoking ban had any effect on heart attacks, the abstract section of the paper states: "At this early stage following the smokefree legislation, there are hints emerging of a positive impact on AMI admissions...".

Also, in the discussion section of the paper, the authors state: "Overall, our results provide onlylimited indication that the introduction of the legislation was associated with a reduction in AMI admissions." [emphasis is mine]

The Rest of the Story

This is now the second published study which fails to find a significant effect of a smoking ban on heart attack admissions. Remember that a much larger study, which included an analysis of all heart attack admissions in the entire country of New Zealand, found no evidence for any effect of the smoking ban on heart attacks. In that study, the implementation of the ban was associated with a slight increase in heart attacks (which seems to be the case during the second year of the smoking ban in Christchurch).

The results of this study are consistent with those of the first, larger study, which studied all hospitals in New Zealand and found no effect of the smoking ban on heart attacks during the first year of the ban. This study examined only Christchurch and while there was a slight decline in heart attacks, the rate of heart attacks actually increased during the second year post-ban.

Besides adding evidence that refutes the conclusion disseminated by anti-smoking groups and by the IOM Committee which reviewed this issue, this story is also important because it shows how biased the reporting of science within the tobacco control community has become. Here we have a study where the paper itself asserts that no causal conclusion can be drawn, yet the media were apparently told that the study showed a reduction in severe heart attacks due to the smoking ban.

Why bother doing the research if you are going to tell the media the same thing no matter how the study results come out?

In addition, the study itself uses misleading, inappropriate, and non-scientific language in describing its findings.

First, it states its conclusion as follows: "there are hints emerging of a positive impact on AMI admissions."

To translate into plain English, this means: "We failed to find the evidence of a positive impact on AMI admissions that we were hoping for. However, we don't want to say that there was no effect found. So instead, we'll weasel our way out by stating that there are hints of an emerging positive impact ... in other words, an impact that hasn't yet been shown, but it is due to emerge at some point since we believe in it."

Second, the paper also states its conclusion as: "Overall, our results provide only limited indication that the introduction of the legislation was associated with a reduction in AMI admissions."

To translate that into plain English, it means: "our results actually don't indicate that the legislation reduced heart attacks. But we don't want to state that, so we'll call it a "limited" indication."

Why can't researchers writing about this issue of smoking bans and heart attacks simply tell it like it is? Why do they have to use non-scientific weasel language to avoid what is apparently a pre-determined conclusion? And how does this get past the peer review of the journal?

Wednesday, March 17, 2010

An Illinois state Senator has introduced legislation that would ban the sale of electronic cigarettes in Illinois. Senator Mattie Hunter (D-Chicago) is sponsoring Senate Bill 3174, which makes it illegal to sell or distribute electronic cigarettes in Illinois.

According to Senator Hunter: "Electronic cigarettes have not been approved by the FDA and we don’t know what is in them or if they are safe. Until these types of products are deemed certified or legal to sell by the FDA, they should be banned throughout Illinois."

The Rest of the Story

Actually, electronic cigarettes have been extensively studied in the laboratory and we have a pretty good idea of what is in them. While we don't know if they are absolutely safe, we do know that they are likely much safer than regular cigarettes.

Laboratory testing has revealed that electronic cigarettes contain mainly propylene glycol, glycerin, and nicotine. There are traces of other chemicals, none of which has been implicated as a health hazard at the concentrations present in the electronic cigarette (with the one exception of diethylene glycol, but that was only found in one e-cigarette brand and many other brands tested have been shown to be free of diethylene glycol).

We do know that electronic cigarettes contain only traces of carcinogens. In fact, the level of carcinogens in these products are comparable to levels present in nicotine replacement products like nicotine gum and the nicotine patch. Importantly, the concentration of carcinogens in electronic cigarettes is orders of magnitude lower than in regular cigarettes.

We also know that many smokers have found electronic cigarettes to be highly effective in helping them to quit smoking and to stay off cigarettes. There are literally thousands of people who would almost certainly return to regular cigarette smoking if electronic cigarettes were taken off the market.

The rest of the story, then, is that Senator Hunter is sponsoring legislation that if enacted would be devastating to the health of the people of Illinois. It would force many ex-smokers in the state to return to cigarette smoking. Thus, it would cause substantial public health harm.

Electronic cigarettes appear to be a much more effective tool for quitting smoking than traditional nicotine replacement therapy. And they certainly appear to be a much safer alternative to cigarettes for smokers who are unable to stop using nicotine products completely.

To take electronic cigarettes off the market is to deny smokers a much safer alternative that is likely saving lives and improving the public health. That such a bill was sponsored by the Vice-Chair of the legislature's Public Health Committee suggests that she simply has not taken the time to properly study the issue of electronic cigarettes.

With all of the facts in hand, I don't see how any legislator who is truly interested in protecting the public's health and saving lives could possibly support legislation to take e-cigs off the market, forcing ex-smokers to return to the much more toxic analog cigarettes. Let's hope that Senator Hunter and her colleagues in the Illinois legislature take the time to research and inform themselves about this issue before they vote on this bill.

Monday, March 15, 2010

Is there a rational basis for letting Safeway sell cigarettes but telling Walgreens that it can't?

That's the question that a California appellate court is trying to answer in considering the appeal of a lawsuit challenging the constitutionality of a San Francisco law that bans the sale of tobacco products in pharmacies. The law only bans the sale of tobacco in some pharmacies. Those that are part of "box stores" are not included. Thus, although many Safeway supermarkets contain pharmacies, the pharmacies within those stores are still allowed to sell cigarettes. However, a large Walgreens store which may sell may products in addition to pharmaceuticals may not sell tobacco products, even though it offers for sale many food and household items.

To make matters worse (and seemingly, more arbitrary), it is not the case that tobacco products cannot be sold at all Walgreens stores. If a Walgreens contains a pharmacy, then it can sell tobacco products. But if a Walgreens is otherwise exactly the same but does not contain a pharmacy, it cannot sell tobacco products.

One of the justices on the three-judge panel of the First District Court of Appeal, which is hearing the case, seemed at very least mildly confused during the hearing about the rationale for allowing cigarette sales at Safeway but not at Walgreens. According to an article on Law.com: "In trying to figure out whether there is a rational basis for letting Safeway sell cigarettes but not Walgreens, [Justice] Pollak said, "what we're comparing is very ephemeral."Given "modern marketing," he said, some stores are a cross between a drug store and a grocery store, and there's no clear line: "It's very hard to think of a product I can buy at Walgreens that I can't buy at Safeway and vice versa.""

According to the article, the attorney for Walgreens "urged the court "not to get hung up" on whether Walgreens counts as a grocery store since, he argued, it was clear that San Francisco intended to include the company in its drug store cigarette sales ban no matter what. Throughout the legislative history, it was all about Walgreens," he said. "An ordinance designed to avoid an implied message doesn't pass the smell test. If it doesn't pass the smell test, it certainly doesn't pass the rational basis test.""

The Rest of the Story

Whether or not there is a rational legal basis for allowing Safeway to sell cigarettes but not Walgreens, and to allow one Walgreens to sell cigarettes but not another Walgreens, there is clearly no rational public health basis upon which to formulate such a law.

The courts have traditionally given very wide discretion to local governments in applying the rational basis test. So the court may very well end up ruling in the city of San Francisco's favor. Nevertheless, it is important to note that from a public health standpoint, there is no rational basis for this law.

If the sale of cigarettes sends a bad message, then why should one Walgreens be allowed to sell cigarettes but not another Walgreens which may be located right down the street? It is very unlikely that the consumer views one Walgreens as having a different mission from another Walgreens, so on what basis is it going to protect the consumer from getting a mixed message by outlawing the sale of cigarettes at one Walgreens but not the other?

Similarly, there is absolutely no public health rationale for banning the sale of cigarettes in a Walgreens that has a very small pharmacy, but not in a Safeway that may have an extremely large pharmacy. If it sends a mixed message for the Walgreens pharmacy to sell cigarettes at a location where drugs are also being sold, then why does it not also send a mixed message for the Safeway store to sell cigarettes at the same location of an even larger pharmacy?

Moreover, if it sends a mixed message to sell cigarettes at a pharmacy, then does it not also send a mixed message to sell junk food and soda at such a location?

I am in no way defending the sale of tobacco products in pharmacies. If I owned a pharmacy, I would certainly not sell tobacco products. However, the public health advocates who pushed for this law are actually supporting the sale of tobacco products. By arguing that the sale of tobacco products is only inappropriate in a pharmacy, they are implying that the sale of tobacco is fine anywhere else. Apparently, there's no problem selling tobacco products in a grocery store that has a pharmacy, or in a gas station, convenience store, or neighborhood market.

This irrational law is representative of a larger problem that I have noticed in the tobacco control movement these days: the loss of rationality to its policy positions. Remember, anti-smoking advocates in San Francisco are also pushing for an ordinance to limit the number of stores that can sell tobacco products in San Francisco to 385. Apparently, if 385 stores sell tobacco products in a city, it is perfectly acceptable, but if 386 stores sell tobacco products, then it is an affront to the public's health.

As another example, the Kansas legislature just declared secondhand smoke to be an extreme danger, so hazardous that it needs to be banned inside any workplace, including bars and restaurants. But the legislature apparently did not find secondhand smoke to be a hazard inside state-owned casinos, which it exempted from the law. Apparently, secondhand smoke has a special property whereby it spontaneously de-toxifies itself when it is present in a state-owned casino.

And perhaps the greatest act of irrationality is the major national anti-smoking groups' support for a ban on electronic cigarettes at the same time as they supported the federal government's explicit approval of the much more toxic analog cigarettes.

The question that arises is this: why is it that the public's health no longer seems to be the driving force behind the tobacco control movement?

Thursday, March 11, 2010

An academic research unit that is apparently serving as the "Duke University branch" of Philip Morris has just put out a study which perpetuates the blinding focus on nicotine biology, thus obscuring the importance of an approach to smoking cessation that actually works and would make a dent in Philip Morris' profits.

The work was carried out by the Duke Center for Nicotine and Smoking Cessation Research (or "Philip Morris South," as I would call it), which received multi-million dollar funding from Philip Morris. As I revealed earlier, according to the agreement between Philip Morris and its "southern affiliate," the director of Duke's nicotine research center (or a designee) becomes a formal part of Philip Morris' public relations efforts, by virtue of appointment to the Advisory Board of the company's "smoker cessation support initiative."

The focus of the Duke Center's work has been on nicotine replacement therapy. It makes sense that the company would be happy to support such research because we know that nicotine replacement therapy (NRT) is dismally effective in getting smokers to quit. There is considerable research that cold turkey and unplanned, unaided quit attempts are more effective in achieving smoking cessation than the use of NRT. Thus, any research which continues to perpetuate the research community's focus on nicotine biology is a win, win situation for Philip Morris. The company not only gets to boast that it is funding research to "help smokers quit," but it can do so while funding a research program that actually impedes progress towards effective cessation strategies by taking the focus off the need for aggressive strategies to promote cessation, rather than a pure reliance on pharmaceuticals.

The research released last week, which was funded by Philip Morris, makes the major contribution of informing us that smokers take up nicotine in their brains more slowly than previously thought.

The implications? A continued need for more research on nicotine biology, taking the focus away from the need for aggressive anti-smoking programs, which are the only effective way of actually making a difference in quit rates.

The Rest of the Story

This research couldn't have been any better planned for Philip Morris than had it been designed by Philip Morris' own public relations department.

Actually, in a way it was, because Duke University is now serving as a PR arm for Philip Morris, by virtue of its accepting this tobacco money to conduct a research program that is clearly going to have the effect of diverting attention away from areas where we could really make a difference in getting people to quit smoking.

For tax or accounting purposes, Philip Morris should really classify these research dollars under "public relations." And they are sure getting their money's worth.

Tuesday, March 09, 2010

The Utah legislature has passed a bill that would almost certainly make it criminal homicide if a smoker has a miscarriage and would allow the woman to be prosecuted, with a maximum penalty of life in prison.

According to Utah law: "A person commits criminal homicide if he intentionally, knowingly, recklessly, with criminal negligence, or acting with a mental state otherwise specified in the statute defining the offense, causes the death of another human being, including an unborn child at any stage of its development."

However, under current Utah law, there are provisions which prevent the state from prosecuting women who miscarry or have an abortion.

The bill - House Bill 12 - would strictly define abortion as performed by a physician under specified circumstances, and would remove the restrictions so that a pregnant woman could be prosecuted if she "recklessly" causes the "death" of an "unborn child."

In order to show that a woman acted in a reckless manner, it merely needs to be shown that the woman's action - smoking in this case - is known to cause miscarriages. Since there is strong evidence that smoking increases the risk of miscarriage, women who smoke during pregnancy and who suffer a miscarriage could be viewed as having acted recklessly. Thus, they would - by Utah state law if this bill is signed by the governor - be guilty of criminal homicide and could face a potential maximum penalty of life in prison.

The Rest of the Story

Besides being the most dangerous intrusion into the rights of woman that I am aware of, this is also the most dangerous intrusion into the autonomy of smokers that I have yet seen. This bill, if enacted into law, would literally allow the state to lock up in prison woman who smoke during pregnancy and experience a miscarriage.

Anti-smoking groups should be among the first protesting against this bill and urging the Governor to veto it. However, to the best of my knowledge, the national anti-smoking groups have been silent.

You know, I talk a fair amount on this blog about the mentality in the anti-smoking movement and where it could potentially lead, but this is no longer in the realm of what could happen. It's here! This is happening before our eyes.

Fortunately, the governor of Utah vetoed this bill yesterday. He then went on to sign an amended bill in which the word "reckless" was removed. The legislation is still an absolute abomination: it makes it criminal homicide for a woman to take the morning after pill. However, the removal of the word "reckless" eliminates the ability of the state to press charges against smokers who suffer a miscarriage.

The Utah legislature and governor are a complete disgrace to America and to our Constitution and the individual rights and autonomy upon which this country was founded. I cannot possibly condemn them strongly enough.

State legislation being considered in Oklahoma would make it a crime - a misdemeanor - for a person to smoke, even outdoors in a remote location, on a campus that has been declared as smoke-free. It would also be a criminal offense to use smokeless tobacco, which has no effect on the health of others, on such a campus.

Of course, getting completely drunk and risking your own and other people's lives would not be a criminal offense unless you actually cause harm to another person. But put a little chew in your mouth in you have automatically committed a misdemeanor.

You can't be serious. How Oklahoma legislators think it makes sense to make it a criminal offense for an individual to take an action which endangers no one other than the person taking that action? Every one of the other misdemeanor offenses listed above involves risks or damage to the public. But smoking in remote areas of a campus poses risk only to the person choosing to smoke. The same is true with smokeless tobacco use.

To be consistent, why does the Oklahoma legislature not want to make it a crime to drink alcohol excessively on the campus? In fact, that is a situation where the lives, well-being, or property of other people may indeed be put at risk.

And the ultimate hypocrisy is that the same legislature which is poised to make it a crime to smoke in the remote areas of a campus has no problem with people smoking in a bar where employees may be exposed heavily to tobacco smoke for more than 40 hours per week.

What if a person is using smokeless tobacco for the express purpose of trying to quit smoking? Should that person have a criminal record just because they are using smokeless tobacco on the campus?

What about a person who is being very respectful of nonsmokers by moving to a location away from other people to smoke? Shouldn't we be grateful to that individual for her courtesy rather than make her a criminal?

Monday, March 08, 2010

It is difficult for me to see any way in which a public health group could praise a state legislature that voted to make it criminal homicide for a woman to take the morning after pill or to suffer a miscarriage induced by an abusive partner or an accident, but the Campaign for Tobacco-Free Kids has done so.

It is also difficult for me to see how a public health group could praise a legislature that has asked its citizens to smoke in order to support critical government programs. But the Campaign for Tobacco-Free Kids has done so.

The Campaign for Tobacco-Free Kids praised the Utah legislature for enacting a $1.00 per pack cigarette tax increase in order to provide funds to support critical government programs that were on the chopping block. The money has already been allocated and none of it is going to anti-smoking programs or programs to provide services to smokers who will be paying the tax, Instead, the revenues are dedicated to save critical government programs that were on the chopping block and would otherwise have had to be cut.

The Rest of the Story

It is not possible for me to express the strength of my condemnation of the Utah legislature for showing such a disrespect for the autonomy of women and for the Constitution, trying to establish a state-based religion by making it criminal homicide for a woman to choose to use a morning after pill or to suffer a miscarriage as a result of the actions of an abusive partner or of an accident. The simple fact that the Utah legislature has made it its business to investigate or have an interest in the circumstances behind every miscarriage suffered in the state (which is about 20% of identified pregnancies, by the way) is sickening.

Now, the Utah legislature has opted to save critical government programs through the most cowardly of policies: a regressive tax that punishes those least able to pay -- the most heavily addicted smokers and their families and children.

Moreover, the Utah legislature has now made it essential for its citizens to continue smoking, or else critical government programs will have to be cut.

Utah is basically telling its citizens who smoke: "Please continue to smoke so that we'll have your tax money to support critical government programs. Don't quit, because if you do, you are putting these critical public programs at risk of being decimated."

If Utah legislators were sincerely concerned about protecting the health of their state's children, they would have allocated revenues to smoking education and prevention programs. In squandering that opportunity, they ensured that the tobacco industry's marketing of tobacco products in Utah will go relatively unopposed. But even worse, in sending the message that cigarette consumption is necessary to support critical public programs, the legislature has made it clear that it really doesn't want smokers to quit. The legislature has made the state dependent on a steady, continuing stream of cigarette revenues for the funding of critical programs and has completely eliminated the incentive for the state to try to reduce cigarette consumption.

In light of the action that the Utah legislature has taken this session, it deserves nothing but condemnation. I would not be so narrow-minded - thinking only about anti-smoking actions - to praise the legislature this session even if it did something that was sincerely intended to reduce tobacco use. But this measure is not sincerely intended to protect children, it is merely a piece of political cowardice: balancing the state's budget in the most politically easy way. But the end result is setting up perverse incentives for the state to make sure that nothing is done that would seriously decrease cigarette consumption.

Here are some T-shirts I have designed to acknowledge the accomplishments of the Utah legislature this session:

"Utah: Where Women Can Go to Jail for Using Legal Contraception"

"Utah: Where Miscarriages Constitute Murder"

"Utah: Where You Can Attend Church at the State House"

"Utah: The Greatest Hypocrites on Earth"

"I Support My State Budget: I Smoke"

"I Care About Critical Government Services: I Will Keep Smoking"

"If You Care About Essential State Programs, Don't Even Think About Quitting"

Thursday, March 04, 2010

A study published in a recent issue of the Annals of Internal Medicine finds that even with continuous use of the nicotine patch for six months, very few smokers were able to stay off cigarettes long-term. In fact, the rates of long-term abstinence with the nicotine patch were far lower than even the lower end of unaided long-term quit rates. The research demonstrates that nicotine replacement therapy is terribly ineffective in achieving smoking cessation, is less effective than unaided quitting, and is probably a waste of time and money on a population basis.

Previous research has shown that unaided quit attempts yield one-year continuous abstinence rates of between 3% and 11%. Gritz et al. found that in high-motivation situations, such as the Great American Smokeout or New Year's Day resolutions, unaided quitting yielded a one-year continuous abstinence rate of 11%. Nevertheless, a generally accepted value for long-term one-year abstinence with unaided quitting is somewhere around 3% or 5%.

So, with that as a background, take a guess as to how many of the 568 subjects in the study of nicotine patch therapy were able to achieve continuous one-year abstinence (half of these subjects used the patch for 2 months and half used it for 6 months).

... None of the above. The actual number of subjects who achieved one-year continuous abstinence with the nicotine patch was 5, or only 0.8% of the sample.

Even assuming that unaided quit attempts yield a long-term continuous abstinence rate of only 3%, use of the nicotine patch did not even come close to achieving a 3% long-term continuous success rate.

Interestingly, despite these results, the paper concludes that extended-therapy nicotine patch therapy is effective. In fact, it only mentions the 0.8% long-term success rate in fine print in the results section, ignoring this critical result in the abstract and discussion section.

Even the point-prevalence abstinence rate at one year with extended-therapy nicotine patch use was a dismal 14.5%, and was no better than the point-prevalence abstinence rate at one year with short-term nicotine patch therapy (14.3%), calling into question the paper's odd conclusion that extended-use nicotine patch therapy is effective.

The Rest of the Story

This study adds to the growing body of research that pharmaceutical treatment of smoking dependence is a dismal intervention and that unaided quitting is more effective than the use of nicotine replacement therapy or other drug approaches. Nicotine replacement therapy has no business being the mainstay of the nation's strategy for smoking cessation.

In light of these findings, one might ask the question of how the paper could possibly conclude that long-term nicotine patch therapy is effective and why it buries its own finding that only 5 of the 568 subjects achieved long-term continuous abstinence.

We can't be sure, but I can tell you for sure that one of the following statements is true. Your role is to figure out which one it is. The choices are:

A. A rate of 0.8% for long-term continuous abstinence is actually very high. If 8 out of 1000 patients quits long-term, that is the sign of a very effective medical treatment.

B. A rate of 0.8% for long-term continuous abstinence is actually very high because long-term quit rates for unaided quit attempts are only about 0.2%.

C. These quit rates are artificially low because people who enter into clinical trials on smoking cessation are a highly unmotivated group.

D. The senior author of the study has a severe financial conflict of interest as she has served as a consultant to GlaxoSmithKline, one company that manufactures the nicotine patch. She has also served as a consultant or has received research funding from AstraZeneca, Pfizer, and Novartis.

The answer is ...

... D. The senior author of the study has a severe financial conflict of interest as she has served as a consultant to GlaxoSmithKline, one company that manufactures the nicotine patch. She has also served as a consultant or has received research funding from AstraZeneca, Pfizer, and Novartis.

The almost laughable irony is that the major anti-smoking groups are calling on electronic cigarettes to be pulled off the market and banned because they are concerned that the long-term success rates of these products may not be very high and they would rather that smokers stick with the "proven" nicotine replacement therapy drugs. But the rest of the story is that of 568 patients treated with these "proven" nicotine replacement drugs, only five achieved long-term continuous abstinence, far fewer than would have been expected with unaided cessation.

The not so laughable irony is that every one of the anti-smoking groups which has called for electronic cigarettes to be pulled off the market because their effectiveness has not been shown to be as "great" as nicotine replacement therapy has a financial conflict of interest with pharmaceutical companies that manufacture the smoking cessation drugs.

Tuesday, March 02, 2010

Yesterday, I reported that the FDA has appointed GlaxoSmithKline to sit on its Tobacco Products Scientific Advisory Committee, by virtue of its appointment of a Glaxo consultant and expert witness to the panel.

Today, I report that the influence of the pharmaceutical industry on FDA policy will be even greater than I suggested yesterday, because three additional members of the Committee have also received pharmaceutical money.

First, the chair of the Committee - Dr. Jonathan Samet - has received grant support from GlaxoSmithKline. In addition, the organization that he directed - the Institute for Global Tobacco Control - is funded by GlaxoSmithKline and Pfizer.

Second, an additional panel member - Dr. Dorothy Hatsukami - has received grant support from a pharmaceutical company to study the nicotine vaccine for use in smoking cessation.

Third, an additional panel member - Dr. Neal Benowitz - co-authored a study on the use of Chantix in smoking cessation which was funded by Pfizer and has also served as a Pfizer consultant. In particular, Dr. Benowitz served as a Pfizer consultant on how to develop a scientific base to support the use of Chantix in smoking cessation. Benowitz has also consulted for GlaxoSmithKline and Nabi Pharmaceuticals.

The Rest of the Story

The FDA Tobacco Products Scientific Advisory Panel is a virtual smorgasbord of tobacco and pharmaceutical financial interests. This is hardly what I imagine President Obama had in mind when in his inaugural address he called for "science to be restored to its rightful place."

The FDA has now given a seat on the panel to GlaxoSmithKline, Pfizer, and Nabi Pharmaceuticals, alongside the tobacco companies, through their paid consultants or grantees.

There is no way this panel can objectively consider tobacco product regulation and policy - based purely on the science - in the midst of such a potpourri of pharmaceutical financial interests and conflicts of interest.

The conflicts of interest of two of the panel members were highlighted in an article in today's Wall Street Journal.

Given that the FDA has already been under siege for complaints about the undue influence of politics over science, due to the influence of industry, it is unclear why the Agency would want to compound the problem by crafting a highly conflicted panel to advise it on tobacco issues. There is enough bias in this field to begin with; we don't need to add to it by appointing a panel with numerous members who have severe, personal financial conflicts of interest.

The rest of the story is that by virtue of its appointment of numerous members with financial conflicts of interest with Big Pharma, the FDA Tobacco Products Scientific Advisory Committee has now become a literal extension of pharmaceutical company financial interests. These companies have been given the gift of a seat at the table (actually, four seats).

This means that 7 of the 12 seats on the panel are now industry seats:

Big Tobacco: 3Big Pharma: 4Total Industry Seats: 7

The tobacco and pharmaceutical industries must be laughing all the way to the bank. There's nothing like sitting on the panel of the Agency that regulates your products or makes decisions about the regulation of the products of your chief competitors.

Not only would President Barack Obama not be eligible to apply for a job with the Memorial Health Care System in Chattanooga, Tennessee, but he would not even be eligible if he was successfully refraining from using tobacco with the help of nicotine replacement therapy.

The Memorial Health Care System recently announced that it would no longer hire anyone who smokes, anyone who uses tobacco in any form, or anyone who uses nicotine products. The policy, which became effective on February 1, 2010, is enforced through a post-offer health screening which verifies that a prospective employee does not use tobacco or nicotine products.

The policy states: "To further our mission of building healthier communities, effective February, 1, 2010, Memorial Health Care System will no longer hire individuals who use tobacco or nicotine products in any form. Memorial Health Care System and its affiliates recognize the major importance of associates’ health and well being, and the responsibility of maintaining a healthy and safe environment for all associates, volunteers, patients and visitors. Therefore, all individuals who are offered a position with Memorial Health Care System or any of its affiliates, are screened for illegal drug, alcohol, and/or tobacco/nicotine use as part of the post-offer health screening. Individuals whose post-offer health screening results are verified positive for illegal drugs, alcohol, and/or tobacco/nicotine use, and/or whose reference and/or background checks are verified unsatisfactory, will be disqualified from employment, their job offer will be withdrawn, and they may be disqualified from applying for employment for six (6) months from the date of the post-offer health screening."

The Rest of the Story

That the Memorial Health Care System would not employ anyone who is trying to quit smoking by use of a nicotine-containing product, such as a nicotine patch or electronic cigarette, pretty much tells you that this policy is not about health. It is about punishing smokers. The primary purpose of the policy, in my view, is to discriminate against smokers and make it more difficult for them to find employment. Why else would you refuse to hire someone who has successfully quit smoking using electronic cigarettes or the nicotine patch?

Clearly, the policy is not about "building healthier communities," as Memorial states. Instead, it is about punishing anyone who now does or recently did choose to smoke. This is lifestyle choice discrimination. It has nothing to do with building a healthier or more effective work force.

What the policy is about is not building healthier communities, but building unhealthy communities in which employment discrimination is accepted.

A recent article in the American Medical News (the newspaper of the American Medical Association) highlighted two opposing viewpoints on this policy. On one side, John Banzhaf, the director of ASH, argued that this employment discrimination is justified because it will save money for the employer.

However, policies that ban overweight people from employment would also save money for the employer. Is ASH also pushing for policies that would prohibit overweight individuals from applying for a job with the Memorial Health Care System?

On the other side, Dr. Alan Blum, professor of family medicine and director of the University of Alabama Center for the Study of Tobacco and Society, argued that: "This gets into personal freedoms, and I'm very uncomfortable with this. This would be very low on my wish list for what hospitals should be doing. What is it about the person who smokes that makes them less qualified?"

Way to go Dr. Blum for speaking out against this employment discrimination and pointing out that the fact that a person smokes does not make them less qualified for a position.

Hopefully, other physicians will join Dr. Blum in taking an active stance against these type of discriminatory employment policies against smokers.

The rest of the story is that the Memorial Health Care System is not in fact promoting a healthier environment. Instead, it is promoting employment discrimination, hatred against, and punishment of a class of individuals based solely on a particular behavioral choice they have made which has no relation to their qualifications for employment.

Monday, March 01, 2010

While it seems bad enough that the tobacco industry is given three seats on a supposed "scientific" advisory committee to guide the FDA in its implementation of the regulation of tobacco products, the FDA made the situation worse today by providing a major pharmaceutical company with a vested, multi-million dollar interest in smoking cessation products a seat at the table as well.

Today, the FDA announced that a GlaxoSmithKline consultant - Dr. Jack Henningfield of Pinney Associates - was appointed to the Tobacco Products Scientific Advisory Committee.

Pinney Associates is a pharmaceutical consulting firm that provides consulting support to GlaxoSmithKline on an exclusive basis regarding tobacco dependence treatment. GlaxoSmithKline is the manufacturer of Zyban and NiQuitin.

In addition to his serving as an exclusive consultant to GlaxoSmithKline specifically on the issue of tobacco dependence treatment, Dr. Henningfield also has a personal financial interest in smoking cessation treatment, as he has a financial interest in a potential new oral nicotine replacement therapy product.

To make matters even worse, Dr. Henningfield has testified in court as an expert witness on behalf of GlaxoSmithKline.

The Rest of the Story

The rest of the story is that Big Pharma now joins Big Tobacco with a seat at the table on the supposedly objective and scientific FDA advisory committee that will guide the Agency in its decisions about the regulation of tobacco products. These regulations will have a major impact on the future profitability of smoking cessation medications. The last individual in the world who you would want to serve on such a panel would be a Big Pharma consultant, especially one who consults specifically in the area of smoking cessation medications. The fact that this individual also has a personal financial interest in such medication and who also has testified in court on behalf of Big Pharma simply adds insult to the public's injury.

That GlaxoSmithKline joins the tobacco companies in having a seat at a supposedly "scientific advisory" table undermines the entire point of the panel and turns the whole thing into a joke, rather than a serious scientific and policy undertaking for the benefit of the public's health.

These type of panels should consist of individual scientists who are impartial and do not have personal financial conflicts of interest with industry, especially if that industry is to be directly regulated by the FDA and if the use and profitability of its products will be directly affected by the national policy decisions that the Agency makes.

For example, one issue that the FDA is going to have to deal with immediately is the regulation of electronic cigarettes. As these products are a tremendous threat to GlaxoSmithKline profits (not to mention Big Tobacco profits), there is no way that the Scientific Advisory Committee can have an objective discussion about this issue.

Unfortunately, the FDA has chosen to invite Big Pharma to the table.

So much for an objective scientific panel. Industry's influence on the FDA just became even bigger, and in a major way.

One of the activities being promoted by the Campaign is a boxing match where youths simulate committing physical violence on a mock tobacco industry representative.

Specifically, the Campaign for Tobacco-Free Kids is calling for kids to set up a boxing match. They are to set up a boxing ring and have a mock tobacco industry representative wearing a suit or cigarette costume. An announcer is to stand in the ring and attract passersby to the ring. They put on inflatable gloves and punch the tobacco industry representative. This activity is recommended for middle school and high school groups.

The centerpiece to the activity is described, word for word, as follows: "Have passersby put on the inflatable gloves and let them punch the tobacco industry representative."

The Rest of the Story

Is it just me, or is this despicable for a public health group? It seems to me that it is completely inappropriate for a public health group to be promoting physical violence - albeit simulated - against individuals.

We should be teaching youths that if they find fault with a corporation's practices and policies, they should use legal advocacy mechanisms - such as the legislative, executive, and judicial branches of government - to try to effect change in society. Simulating the commission of physical violence against the executives of that corporation is not only inappropriate, but undermines the very message we are supposed to be sending to our children.

The Campaign for Tobacco-Free Kids will apparently stoop as low as it needs to in order to misuse kids to serve the organization's own political purposes. Previously, I highlighted how the Campaign misused young people, through its bogus Youth Advocates of the Year awards, to serve its pet political goal of passing the FDA tobacco legislation. The Campaign hid the truth from youths, hoping to recruit them to its political goals by deceiving them about the facts behind the FDA legislation.

Now, the Campaign has stooped to a new low: promoting the idea of physical violence as a means of reacting to corporate wrongdoing and teaching this to our youths.

I think the Campaign has an obligation to not only delete the boxing match from its activity guide for Kick Butts Day, but to send out a message apologizing to youths throughout the country for suggesting and incorporating physical violence against identified individuals into a public health activity.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.